Avanos Medical, Inc.: Device Recall

Recall #Z-2422-2024 · 05/31/2024

Class II: Risk

Recall Details

Recall Number
Z-2422-2024
Classification
Class II
Product Type
Device
Recalling Firm
Avanos Medical, Inc.
Status
Ongoing
Date Initiated
05/31/2024
Location
Alpharetta, GA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
53,384 kits

Reason for Recall

The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

Product Description

MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, sterile, all product codes beginning with the following numbers: 1. 0270-14- - 14 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 2. 0270-16- - 16 Fr, all sizes except 6.0 cm and 6.5 cm - Non-ENFit; 3. 0270-18- - 18 Fr, all sizes - Non-ENFit; 4. 0270-22- - 22 Fr, all sizes - Non-ENFit; 5. 8270-14- - 14 Fr, all sizes (ENFit); 6. 8270-16- - 16 Fr, all sizes (ENFit); 7. 8270-18- - 18 Fr, all sizes (ENFit); 8. 8270-22- - 22 Fr, all sizes (ENFit).

Distribution Pattern

Worldwide distribution - US Nationwide - There was also government and military distribution and the countries of Canada and Australia.

Other Recalls by Avanos Medical, Inc.

View all recalls by Avanos Medical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.